Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Omeprazole Delayed-Release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Affected NDC
62175-0118-43
Compare with the code on your package — it is the most precise check available.
Drug: Omeprazole Category: Heartburn & Stomach Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Omeprazole NDC 62175-0118 |
20 mg/1 | Capsule, Delayed Release Oral |
Lannett Company, Inc. | Rx |
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-009-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Omeprazole recalls
See all
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Good Sense Omeprazole Tablet 14ct Sku 900055 Prilosec OTC…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Other recalls by Kremers Urban Pharmaceuticals, Inc.
All 2013 recalls
Class II · Moderate risk
Nitroglycerin Transdermal System 0.4 mg/hr
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.